Clinical Trial: Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07)

Brief Summary: The purpose of this study is to determine whether a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma is tolerable.

Detailed Summary: As medulloblastoma in adult patients are very rare (1.1% of all brain tumors), adults are often treated in the scope of expanded access treatments or within pediatric studies; although, it is not known whether medulloblastomas act in the same way in adulthood and in childhood. This is the first study to investigate the significance of a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma with the purpose to have a starting point for the development of chemotherapeutical protocols in adults.
Sponsor: University of Regensburg

Current Primary Outcome: feasibility of the adjuvant chemotherapy [ Time Frame: participants will be followed for the duration of chemo therapy, an expected average of 1 year ]

The main objective is the feasibility of the adjuvant chemotherapy which has gained the best results when combined with radiotherapy so far.

The present protocol is primarily to determine the number of interruptions of the maintenance chemotherapy due to toxicity and the kind of toxicity .



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of performable cycles in chemo therapy [ Time Frame: participants will be followed for the duration of chemo therapy, an expected average of 6 months ]
    It should be determined how many cycles in the maintenance chemotherapy are feasible.
  • 3 and 5 years progression-free survival [ Time Frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years ]
    The 3 and 5-years rate of progression-free survival (pfs) should be determined for adult patients.
  • event-free survival [ Time Frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years ]
    The event-free survival (efs) should be determined for adult patients.
  • overall survival [ Time Frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years ]
    The overall survival (os) should be determined for adult patients.
  • course of cognitive performance/QoL [ Time Frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years ]
    The course of the cognitive performance and the quality of life should be observed.


Original Secondary Outcome: Same as current

Information By: University of Regensburg

Dates:
Date Received: April 26, 2012
Date Started: January 2009
Date Completion: March 2021
Last Updated: October 31, 2016
Last Verified: October 2016